Ab-Externo MicroShunt versus Trabeculectomy in Primary Open-Angle Glaucoma
Authors: Joseph F. Panarelli, Marlene R. Moster, Julian Garcia-Feijoo, Brian E. Flowers, N. Douglas Baker, Howard S. Barnebey, Davinder S. Grover, Anup K. Khatana, Bonny Lee, Tuan Nguyen, Michael C. Stiles, Omar Sadruddin, Peng T. Khaw, Steven Vold, Michael McFarland, Michael Stiles, Ann Stechschulte, Amanda Strom, Adam Reynolds, Robert Noecker, Joseph Thimons, Mahmoud Khaimi, Evan Allen, Steve Sarkisian, Howard Barnebey, Ernesto Golez, Robert Feldman, Nicholas Bell, Lauren Blieden, Louis Cantor, Darrell WuDunn, Yara Catoira-Boyle, Huiyi Chen, Joshua Evans, Elizabeth Martin, Yasemin Sozeri, Vinita Srivastava, Ryan Wise, Kenneth Schwartz, Davinder Grover, Michelle Butler, Matthew Emanuel, Ronald Fellman, David Godfrey, Oluwatosin Smith, Helen Kornmann, Anup Khatana, Daniel Hagee, Brian Kuhlman, Jeffrey Zink, Marlene Moster, Elizabeth Dale, Michael Pro, Douglas Baker, Megan Chambers, David Lehmann, Joseph Caprioli, Brian Francis, JoAnn Giaconi, Simon Law, Kouros Nouri-Mahdavi, Anne Coleman, William Flynn, Edward Rashid, Charles Reilly, Robert Rice, Paul Sidoti, Joseph Panarelli, Reena Garg, Tak Yee Tania Tai, Kate Vinod, Noga Harizman, Robert Ritch, George Reiss, Vinay Dewan, Shamil Patel, Christina Sorenson, Christine Larsen, Thomas Samuelson, Mark Hansen, Tara Barth, Alyson Blakstad, Mark Buboltz, Ahmad Fahmy, Mona Fahmy, Kate Montealegre, Martin Mizener, Peter Whitted, Michele Lim, James Brandt, Annie Baik, Angela Jiang, Steve V.L. Brown, Adam C. Breunig, Madhu S.R. Gorla, Isabelle Riss, Garcia Feijoo, Carmen Mendez Hernandez, Jose Martinez de la Casa, Mauro Dupré Pelaez, Ana Fernandez Vidal, Sofia García Sáenz, Laura Morales Fernandez, Federico Sáenz Francés, Enrique Santos Bueso, Lucia Perucho Gonzalez, Henny J.M. Beckers, Stefani Kujovic, Marco Nardi, Maria N. Maglionico, Francesco Nasini, Andrea Passani, Nick Strouthidis, Keith Barton, Jonathan Clarke, Gus Gazzard, Hari Jayaram, Peng Khaw, Maria Papadopoulos, Renata Puertas, Marta Toth, David Lunt, Giacinto Triolo, Ronald Kam, Jason Levine, Brian Flowers, Unni Nair, Steven Simmons, Michael Pokabla
Journal: Ophthalmology (2023)

PurposeTo compare the effectiveness and safety of the MicroShunt (Santen Inc., Emeryville, CA, USA) versus trabeculectomy in patients with primary open-angle glaucoma (POAG).DesignProspective, randomized, multicenter trial conducted in the United States and Europe.ParticipantsAdult patients (aged 40-85 years) with mild to severe POAG inadequately controlled on maximum tolerated medical therapy and intraocular pressure (IOP) ≥15 mmHg and ≤40 mmHg.MethodsPatients were randomized 3:1 to standalone MicroShunt implantation (n=395) or trabeculectomy (n=132), both augmented with mitomycin C (MMC) 0.2 mg/mL for 2 minutes.Main Outcome MeasuresThe primary effectiveness endpoint was surgical success, defined as ≥20% reduction in mean diurnal IOP from baseline with no increase in glaucoma medications. Secondary endpoints included changes in mean IOP and medication use from baseline and the need for postoperative interventions.ResultsAt 2 years, the rate of surgical success was lower in the MicroShunt than in the trabeculectomy group (50.6% versus 64.4%, p=0.005). Mean diurnal IOP was reduced from 21.1 ± 4.9 mmHg at baseline to 13.9 ± 3.9 mmHg at 24 months in the MicroShunt group and from 21.1 ± 5.0 mmHg at baseline to 10.7 ± 3.7 mmHg at 24 months in the trabeculectomy group (p<0.001 compared with baseline in both groups). Mean medication use decreased from 3.1 to 0.9 in the MicroShunt group and from 2.9 to 0.4 in the trabeculectomy group (p<0.001 compared with baseline in both groups). Adverse events at 2 years were generally similar in the two groups, except that hypotony was more common in eyes undergoing trabeculectomy (51.1% versus 30.9%, p<0.001). Repositioning or explantation of the implant occurred in 6.8% of MicroShunt patients. The majority of these patients had device removal at the time of subsequent glaucoma surgery. Vision-threatening complications were uncommon in both groups.ConclusionAt 2 years, both the MicroShunt and trabeculectomy provided significant reductions in IOP and medication use, with trabeculectomy continuing to have greater surgical success.